DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 14 – 22 and newly added claim 23 are pending.
Claims 14 – 15, 17 and 23 are rejected.
Claims 16 and 18 – 22 are withdrawn.
Election/Restriction
Applicant’s election without traverse of Group I (claims 14 – 19) in the reply filed on August 18, 2026 is acknowledged. It is noted that Examiner inadvertently did not address the limitations of claims 18 – 19 as part of the Election of Species (points (6) – (11) in the action dated June 18, 2026) requirement. Claims 18 – 19 are directed to a method for screening a composition for preventing or treating cancer, which is also a process of use of the composition of Group II. Therefore, claims 18 – 19 were not restricted separately. Newly added claim 23 is directed to the method of claim 14, wherein the method is a method for treating cancer. Claim 23 requires all of the limitations of claim 14 and is hereby grouped in Group I. The new Group I is claims 14 – 19 and 23.
Additionally, it is noted that the basis of election of species requirement for Group I and Group II (points (10) – (11)) were swapped and misidentified. The proper requirement (as correctly pointed out by the Applicant) is presented below:
If Invention II is elected, Applicant is required under 35 U.S.C. 121 to elect a single species of the agent (PIP4K2C inhibitor), or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Emphasis added.
If Invention I is elected, Applicant is required under 35 U.S.C. 121 to elect (a) a single species of the agent (PIP4K2C inhibitor), and (b) a single cancer to be prevented or treated, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Emphasis added.
Examiner acknowledges and appreciates Applicant’s careful review of the restriction requirement.
Regarding election of species, Applicant specifically elected Ivacaftor as the PIP4K2C inhibitor, and Rhabdomyosarcoma as a single cancer to be prevented or treated.
Examination: Applicant specifically elected the method for preventing or treating cancer comprising a step of administering a PIP4K2C inhibitor as an active ingredient to a subject. The election reads on claims 14 – 15, 17 and 23. The species of Ivacaftor and Rhabdomyosarcoma are allowable over the prior art. In accordance with MPEP §803.02, the search has been further extended to include the scope, wherein the cancer is soft tissue sarcoma. Claims 16 and 18 – 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim.
Priority
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on November 30, 2021. It is noted, however, that applicant has not filed a certified copy of the KR’747 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 29, 2024 and August 18, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informality:
Lines 2-4 of the claim: The limitation “… small molecule compound selected from the group consisting of dutasteride, aprepitant, ivacaftor, adapalene, and pharmaceutically acceptable salts thereof” is grammatically incorrect because it does not recite proper singular form and Markush group language for the group of alternatives. In order to overcome the objection, Applicant may amend the limitation as follows: “… small molecule compound selected from the group consisting of dutasteride, aprepitant, ivacaftor, and adapalene, or a salt
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 14 – 15 and 23 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method for preventing or treating cancer comprising a step of administering a PIP4K2C inhibitor as an active ingredient to a subject.
The present description generically defines the term “treatment” as “(a) inhibiting the progress of a disorder, disease or symptom; (b) alleviating the disorder, disease or symptom; or ( c) eliminating the disorder, disease or symptom”. See, e.g., paragraph [0023]. The specification further discloses a specific embodiment, wherein the PIP4K2C inhibitor is “dutasteride, aprepitant, ivacaftor, adapalene, and pharmaceutically acceptable salts thereof”. See, e.g., paragraph [0028]. However, there is no guidance provided for the method for preventing or treating cancer administering the wide range of all of PIP4K2C inhibitors. Thus, the scope of the claims is directed towards administering the entire scope of all of PIP4K2C inhibitors as active ingredients to a subject.
MPEP §2163(II)(A)(3)(a)(ii) states the guidelines for the written description as presented below:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the disclosure broadly states the use of PIP4K2C inhibitors in methods for preventing or treating cancer, the generic recitation fails to provide sufficient support to show that the Applicant was in possession of administering wide range of all of PIP4K2C inhibitors as active ingredients. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP §2163(II)(A)(3)(a)(ii) recites the definition of “representative number of species” as:
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) … The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 … Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.”
The present specification does not sufficiently provide support for using a number of species that are representative of the entire genus of all of PIP4K2C inhibitors. For example, MedChemExpress discloses 19 different species of inhibitors of PIP4K2C. See, e.g., pages 1-3. The structures of some inhibitors are presented below:
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. See, pages 1-3, MedChemExpress, Retrieved on September 5, 2026, https://www.medchemexpress.com/us/en/search.html?q=pip4k2c&page=1&page Size=50&srsltid=AfmBOoq8DzITBBPN85hSeLx8JIkkc49Diuu3o8xbzqFKHpD7E3rHyr2G.
There is a significant variation within all PIP4K2C inhibitors, and the present specification does not adequately describe any specific examples to resemble the variation within the entire genus of all PIP4K2C inhibitors. According to Teuscher 2014, “[a]rea under the curve or AUC is a pharmacokinetic statistic used to describe the total exposure to a drug. More specifically, it is the time-averaged concentration of drug circulating in the body fluid analyzed (normally plasma, blood or serum) … The total AUC or A0-∞ is the area under the curve from time 0 extrapolated to infinite time”. See, page 1, Teuscher, N. (2014 Feb. 24). Extrapolating AUC to Infinity. Certara. Retrieved on September 5, 2026, from <https://www.certara.com/knowledge-base/extrapolating-auc-to-infinity/>. The area under the curve is the combination of the absorption phase and elimination phase of a drug.
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While general rules exists, the actual rates of absorption and elimination are unpredictable. For example, according to Revathi, “[a]s a general rule, “the bioavailability of a drug from various dosage forms decrease in the following order: Solutions > Emulsions > Suspensions > Capsules > Tablets > Coated Tablets > Enteric Coated Tablets > Sustained Release Products”. See, page 36, Revathi, J. (2015 Jul. 10). Factors Affecting Absorption. World Documents. Retrieved on September 5, 2026, from <https://vdocuments.net/factors-affecting-absorption.html?page=5>. The unpredictability of absorption and elimination arises from numerous pharmaceutical factors as well as patient related factors. Revathi provides the following list of relevant factors throughout pages 5-7:
Pharmaceutical Factors
Physicochemical properties of the drug
Solubility and dissolution rate
Particle size and effective surface area
Polymorphism and amorphism
Pseudopolymorphism (hydrates/solvates)
Salt form
Lipophilicity
Stability
Stereochemistry
Formulation factors:
Disintegration time
Manufacturing variables
Dosage form
Ingredients (excipients)
Product age
Storage conditions
Patient Related Factors
Age
Gastric emptying time
Intestinal transit time
Gastrointestinal pH
Diseased states
Blood flow through GI tract
GI contents
Other drugs
Food
Fluids
Other contents
Presystemic metabolism by:
Luminal enzymes
Gut wall enzymes
Bacterial enzymes
Hepatic enzymes
The large number of variables affecting plasma concentration of a drug makes the AUC a highly challenging number to predict. In fact, the complexity of many of the factors outlined above creates a substantial challenge to predicting the factors themselves. It would highly unpredictable how each of the factors would affect the overall pharmacokinetic properties of the drugs. A person having ordinary skill in the art would reasonably understand that, if given a specific AUC value, the precise formulation and patient profile cannot be deduced. There are simply too many variables that affect the AUC in order to provide a PHOSITA with any reasonable structure-function correlation between an AUC value and specific pharmaceutical and patient profiles. Thus, a person having ordinary skill in the art would recognize that the Applicant was not in possession of the pharmaceutical compositions comprising the entire genus of all of the serine protease inhibitors. Thus, the present claims do not comply with the written description requirement.
The specification does not provide an adequate written description to convey that the inventors were in possession of the claimed methods. The disclosure does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the pharmaceutical composition comprising the complete scope of all serine protease inhibitors for use in the method for the treatment or prevention of viral infections. In order to overcome the rejection, Applicant may amend claim 1 to recite specific PIP4K2C inhibitors (as claimed in dependent claim 17), that are properly supported by the present specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 14 – 15, 17 and 23 are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
Claim 14 is directed to a method for preventing or treating cancer comprising a step of administering a PIP4K2C inhibitor as an active ingredient to a subject. The claim only requires administering a PIP4K2C inhibitor as an active ingredient to a subject, but it does not state or provide any guidance/ limitations for the type of administration and subject (patient population) of said cancers. The missing limitations lead to a gap between the PIP4K2C inhibitors and the method of administering for preventing or treating cancer in a subject. The specification discloses (see, e.g., paragraphs [0024]-[0025]) (Emphasis added):
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The disclosure provides sufficient guidance for the type of administration and the patient population (e.g., administering a therapeutically effective amount of a PIP4K2C inhibitor as an active ingredient to a subject in need thereof) in the method.
In order to overcome the rejection, Applicant may amend claim 14 as follows: “A method for preventing or treating cancer comprising a step of administering a therapeutically effective amount of a PIP4K2C inhibitor as an active ingredient to a subject in need thereof”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14 – 15, 17 and 23 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Li et al. WO2019/042470 A1 evidenced by English translation of Li et al. WO2019/042470 A1, https://translationportal.epo.org/emtp/translate/?ACTION=description-retrieval&COUNTRY=WO&ENGINE=google&FORMAT=docdb&KIND=A1&LOCALE=en_EP&NUMBER=2019054744&OPS=ops.epo.org/3.2&SRCLANG=ko&TRGLANG=en, Retrieved on September 5, 2026.
Li et al. teach compound 24 as presented below:
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. See, e.g., Table 1, page 24.
Li et al. teach that compounds “block the interaction between SIRPα (signal regulatory protein α) protein and CD47”. See attached English translation, e.g., paragraphs [0001] and [0007]. Further, Li teaches a method for treating diseases mediated by the interaction between SIRPα and CD47, the method comprising administering the compound to a desired subject. See, e.g., paragraph [0168]. The binding affinity of the compound to recombinant human SIRPα protein was tested (see, e.g., Table 1, paragraph [0236]) as presented below:
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The drug is used to inhibit several tumors, including soft tissue sarcoma. See, e.g., paragraphs [0055] and [0075]. MPEP §2112.01(I)-(II) states:
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)… Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Since Li et al. teach compound 24 has great binding affinity to recombinant human SIRPα protein and the compounds block the interaction between SIRPα protein and CD47, the compound would inherently also possess the same properties to inhibit soft tissue sarcoma in a subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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